Alira Health
Alira Health
Alira Health — өмір туралы ғылымдар саласындағы ұйымдарға қызмет көрсететін жаһандық денсаулық сақтау жөніндегі консалтинг және технология компаниясы. Оның қызметі зерттеу және клиникалық әзірлеу, нормативтік талаптарға сәйкестік, басқару консалтингі, пациенттерді тарту және нарыққа қолжетімділікті, сондай-ақ өмір туралы ғылымдар саласындағы зерттеулерді қолдауға арналған технологиялық шешімдерді қамтиды. Компания эмпатияға, ғылыми жетістіктерге, пациенттердің нәтижелеріне, экологиялық тұрақтылыққа, қоғамдастыққа қатысуға және ESG бастамаларына баса мән береді.

Senior Clinical Research Associate - Romania (Remote)

Alira Health is seeking a Senior Clinical Research Associate for remote, part-time work in Romania. The role monitors oncology trials, supports GCP compliance, and mentors CRA teams.

Сипаттама

  • Independently oversee clinical trial site monitoring activities
  • Lead and guide the planning and delivery of clinical trials
  • Maintain protocol compliance, quality standards, SOP adherence, timelines, and budget controls
  • Review monitoring reports and complete co-monitoring and evaluation visits
  • Schedule and complete investigator site visits on time
  • Partner with cross-functional teams to address clinical trial monitoring challenges
  • Support monitoring plans, training materials, ethics submissions, and site contract negotiations
  • Submit monthly billing details to the finance team
  • Oversee study budgets and serve as the sponsor contact for standalone projects
  • Conduct qualification, initiation, interim, and close-out visits both remotely and onsite
  • Produce precise monitoring reports documenting site issues, corrective actions, protocol deviations, study status, and enrollment
  • Check source records and protect the integrity of CRF data
  • Conduct quality checks and verify eTMF and TMF documentation
  • Track investigational product accountability and inspect site regulatory files
  • Maintain ongoing communication with sites about protocol and GCP compliance, patient recruitment, and sponsor requests
  • Apply ICH GCP, FDA regulations, and company and sponsor SOP requirements
  • Support adverse event reporting and reconcile SAE records against source documents and CRFs
  • Address data discrepancies with internal CRAs, CTC, and data management teams
  • Recognize site-level risks and develop practical resolution plans
  • Help sites prepare for audits
  • Coach CRAs and support their onboarding and training
  • Contribute to the development and upkeep of the Clinical Trial Management System (CTMS)
  • Balance competing priorities and handle other assigned responsibilities

Талаптар

  • At least three years of clinical monitoring experience in pharmaceuticals, biotechnology, or a CRO
  • Capability to manage monitoring work independently
  • Willingness and availability to travel throughout Romania
  • Previous oncology experience
  • Fluency in Romanian and English; additional languages are advantageous
  • Strong written and spoken command of the local language used for monitoring activities
  • Degree in a scientific or health-related discipline
  • Proficiency in English
  • Careful, thorough, quality-oriented, and highly attentive to detail
  • Excellent organization and the ability to manage multiple tasks in a fast-paced setting
  • Strong prioritization, time-management, and problem-solving abilities
  • Effective analytical, negotiation, meeting management, cross-functional collaboration, and leadership skills
  • Willingness to travel and ability to work effectively under stress
  • Professional, reliable, and disciplined approach
  • Ability to address unclear or unstructured problems
  • Excellent communication and interpersonal skills with a customer-focused mindset
  • Competence with computers, including clinical trial management systems, trial databases, and electronic data capture tools
  • Working knowledge of clinical research, ICH GCP, local regulations, and regulatory and ethical standards
  • Ability to build and sustain constructive relationships with sponsors, sites, and project teams
  • Bachelor of Science in Biology, Biotechnology, Life Sciences, Pharmacy, or a related field

Артықшылықтар

  • Remote work from Romania
  • Part-time employment arrangement
  • Freelance or contingent workforce engagement

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